BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P960043 · Decision Apr 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
    PMA Number
    P960043
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 30, 1997
    Date Received
    November 26, 1996
    Expedited Review
    Y
    Docket Number
    97M-0274

    Advisory Committee Statement

    APPROVAL FOR THE PROSTAR(R) PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM. THE PROSTAR(R) PVS SYSTEM CONSISTS OF THE PROSTAR(R) PVS DEVICE (9 AND 11 FRENCH SIZES) AND THE FOLLOWING ACCESSORIES: A PROSTAR(R) PRE-DILATOR (9 AND 11 FRENCH SIZES), A PERCLOSE(R) KNOT PUSHER, AND PROSTAR(R) TRANSITION GUIDEWIRE, AND A PERCLOSE(R) ARTERIAL TAMPER. THE PROSTAR(R) PVS SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURES FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE ANC REDUCING THE TIME TO HEMOSTASIS AND AMBULATION (TIME-TO-STANDING) OF PATIENTS WHO HAVE UNDERGONE INTERVENTIONAL PROCEDURES USING 8 TO 11 FRENCH SHEATHS

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MGB Device, Hemostasis, Vascular